Focused Ultrasound
Focused Ultrasound Treatment for Essential Tremor Now Covered by Medicare
Focused ultrasound is a non-invasive surgical procedure for Essential Tremor that can’t be controlled with medication. For some people, focused ultrasound may be an alternative to deep brain stimulation surgery.
Focused Ultrasound Therapy
Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with essential tremor. This novel technology focuses multiple beams of ultrasound energy precisely and accurately on targets deep in the brain without damaging surrounding normal tissue.
How it Works
Where the focused ultrasound beams converge, they produce precise ablation (thermal destruction of tissue), enabling ET to be treated noninvasively. The primary target is a region in the thalamus called the ventral intermediate nucleus (Vim), but other adjacent targets and white matter pathways are also in use.
What is focus in ultrasound?
How Does Focused Ultrasound Work? Similar to how a magnifying glass can focus beams of light on a single point, focused ultrasound uses an acoustic lens to concentrate multiple sound waves on a point in the body. Your providers use magnetic resonance imaging (MRI) to guide the waves and target diseased tissue.
Focused ultrasound treatment for essential tremor has been approved by the Food and Drug Administration (FDA) in July 2016. Medicare approved the treatment in all US states as of July 12, 2020.The
FDA approved staged bilateral treatment for essential tremor on December 20, 2022. Treatments are approved for the second side at least 9 months after the initial treatment.
Focused ultrasound is the marriage of two innovative technologies:
· focused ultrasound—which provides the energy to treat tissue deep in the body precisely and noninvasively, and
· magnetic resonance or ultrasound imaging—which is used to identify and target the tissue to be treated, guide and control the treatment in real time, and confirm the effectiveness of the treatment.
The fundamental principle is analogous to using a magnifying glass to focus beams of sunlight on a single point to burn a hole in a leaf. With focused ultrasound, an acoustic lens is used to concentrate multiple intersecting beams of ultrasound on a target deep in the body with extreme precision and accuracy. Depending on the design of the lens and the ultrasound parameters, the target can be as small as 1×1.5mm or as large as 10x16mm in diameter.
Where each of the individual beams passes through the tissue, there is no effect. But, at the focal point, the convergence of the multiple beams of focused ultrasound energy results in many important biological effects, creating the possibility of treating a variety of medical disorders.
Focused ultrasound treatments can be performed on an outpatient basis, require no incisions, and can result in minimal discomfort and few complications, allowing for rapid recovery.
Reimbursement News: Focused Ultrasound for Essential Tremor Now Covered by Humana
- Humana is the fifth national payor in the US to cover focused ultrasound treatment for essential tremor (ET).
- This decision means that 9 million more people in the US will have access to focused ultrasound for ET.
- Cigna, Anthem, Aetna, Blue Cross Blue Shield, and Medicare have also granted positive coverage decisions nationwide.
Advantages
- It is a noninvasive, single treatment that enables patients to recover rapidly and quickly return to activities of normal life (usually the next day).
- Compared to RF ablation or DBS, focused ultrasound offers a reduced risk of infection, of damage to the non-targeted area, and of blood clot formation.
- Focused ultrasound offers rapid resolution of symptoms.
- In contrast to lesioning performed with stereotactic radiosurgery, focused ultrasound does not use ionizing radiation, thus avoiding the side effects of exposure to radiation.
- Because it is non-invasive, focused ultrasound could be an option for medically refractory ET patients (those who do not respond well to medication) who do not want to undergo surgery.
What is Exablate Neuro?
High intensity focused ultrasound waves precisely target a focal point in the Vim nucleus of the thalamus, the tiny part of the brain that is thought to be responsible for causing tremors. The Exablate Neuro ultrasound transducer consists of 1024 beams that generate enough heat to ablate the targeted tissue during treatment. The result is an immediate and significant reduction of tremor for patients.
During planning and treatment for essential tremor, the patient is fully conscious and lying on the treatment bed in an MRI scanner. MRI provides high resolution visualization, patient-specific treatment planning and continuous monitoring of the procedure. Real-time thermal feedback allows the physician to control and adjust the treatment, ensuring that the targeted tissue is completely ablated without impacting adjacent healthy tissue.
This revolutionary, non-invasive treatment offers a life changing treatment to patients with essential tremor.
Efficacy results3 year follow up pivotal study of focused ultrasound for Essential Tremor¹ (See chart)
Percentages represent tremor improvement over baseline.
1 Pre-Market Approval (PMA) P150038
Safety resultsInsightec-sponsored clinical studies have shown that the most common adverse events experienced after treatment included: imbalance/gait disturbance (26%), numbness/tingling (33%), and headache/head pain (51%). Most of these events were classified as mild or moderate, and 48% of all adverse events resolved on their own within 30 days.
Adverse events that persisted at 3 years were all mild or moderate and included: numbness/tingling (9%), imbalance (4%), unsteadiness (4%), gait disturbance (2%), and musculoskeletal weakness (2%). Additional infrequent events include dizziness, taste disturbance, slurred speech, fatigue and vomiting.
The number in parenthesis is the percentage of active subjects experiencing these adverse events.
For additional safety information, please refer to Pre-Market Approval (PMA) P150038
Percentages represent tremor improvement over baseline.
1 Pre-Market Approval (PMA) P150038
Safety resultsInsightec-sponsored clinical studies have shown that the most common adverse events experienced after treatment included: imbalance/gait disturbance (26%), numbness/tingling (33%), and headache/head pain (51%). Most of these events were classified as mild or moderate, and 48% of all adverse events resolved on their own within 30 days.
Adverse events that persisted at 3 years were all mild or moderate and included: numbness/tingling (9%), imbalance (4%), unsteadiness (4%), gait disturbance (2%), and musculoskeletal weakness (2%). Additional infrequent events include dizziness, taste disturbance, slurred speech, fatigue and vomiting.
The number in parenthesis is the percentage of active subjects experiencing these adverse events.
For additional safety information, please refer to Pre-Market Approval (PMA) P150038
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